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Quality Risk Management Approach for Drug Development and Its Future Prospectives

Authors :
Muthukumar Subramanian
Keshamma E.
Deepika Janjua
Devinder Kumar
Roshan Kumar
Purabi Saha
Rakesh Kumar Gupta
Shuaib Rao
Muthukumar Subramanian
Keshamma E.
Deepika Janjua
Devinder Kumar
Roshan Kumar
Purabi Saha
Rakesh Kumar Gupta
Shuaib Rao
Source :
Journal for Research in Applied Sciences and Biotechnology; Vol. 1 No. 3 (2022): August Issue; 166-177; 2583-4053
Publication Year :
2022

Abstract

These days, finding new marketing authorizations, guaranteeing regulatory compliance, and keeping labour costs competitive are extremely tough. Many pharmaceutical companies also struggle to deal with local regulatory issues and stay up with changes in key pharmaceutical markets. Regulations are thoroughly reviewed before being given to the RA department. This team compiles the most critical prescription information for global approval and marketing. This category accepts both new and revised product submissions. This is mostly handled by the RA department. RA's job is to provide feedback on proposed or disputed legislation. This is a proactive measure. The ICH framework allows for more early intervention. Regulators have a wide range of responsibilities. In the US, the FDA must register and clear the goods with the export company's regulatory professional.

Details

Database :
OAIster
Journal :
Journal for Research in Applied Sciences and Biotechnology; Vol. 1 No. 3 (2022): August Issue; 166-177; 2583-4053
Notes :
application/pdf, English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1346141722
Document Type :
Electronic Resource